Drugs / TAK-994
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04833049 | Apr → Jun 2021 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT04745767 | Feb → Mar 2021 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT04551079 | Sep → Dec 2020 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03933488 | May 2019 → Mar 2020 | — | Takeda | Completed | No outcome recorded |
| Phase 22 trials · 2 met primary | ||||||
| Phase 2 | NCT04820842 | Apr → Nov 2021 | narcolepsy 1 | Takeda | Terminated | Met primary |
| Phase 2 | NCT04096560 | May 2020 → Nov 2021 | narcolepsy 1, narcolepsy without cataplexy | Takeda | Terminated | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-07-26 | Takeda | Results The New England Journal of Medicine Publishes Data from Phase 2 Study of First Oral Orexin Receptor 2 Agonist TAK-994 in Patients with Narcolepsy Type 1 takeda.com ↗
Takeda (TSE:4502/NYSE:TAK) today announced that data from the Phase 2 study of orexin receptor 2 (OX2R) agonist TAK-994 in patients with narcolepsy type 1 (NT1) was published in The New England Journal of Medicine . |
| 2021-10-28 | Takeda | Results Takeda Delivers Strong H1 FY2021 Results; Further Growth Momentum Expected Through Fiscal Year-End Driven by 14 Global Brands takeda.com ↗
Suspended dosing of patients in two Phase 2 studies of TAK-994, an investigational oral orexin agonist for the treatment of narcolepsy type 1 (NT1), after a liver toxicity signal emerged in two clinical studies. |
| 2021-10-05 | Takeda | Results Takeda Provides Update on TAK-994 Clinical Program takeda.com ↗
As an immediate precautionary measure, the company has suspended dosing of patients and has decided to stop both Phase 2 studies early. |
| 2021-07-28 | Takeda | Regulatory U.S. Food and Drug Administration Grants Breakthrough Therapy Designation to Takeda’s Investigational Compound, TAK-994, an Oral Orexin Agonist in Clinical Development for Narcolepsy Type 1 (NT1) takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994, 1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors. |
All press releases naming this drug 4 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TAK-994 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03933488 ↗ |
| Action | Activate | “TAK-994, an oral orexin receptor 2-selective agonist” PMID 37494485 ↗ Jul 2023 |
| Route | Oral | “TAK-994 tablet or matching placebo, orally” NCT03933488 ↗ |